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REGULATORY AFFAIRS MANAGER (m/f/d) – Medical Device

Triga Consulting · Germany
Location
Germany
Work mode
Hybrid
Type
Full-time
Seniority
Manager
Salary
Not stated
Department
Medizintechnik
Languages
DE, EN
Posted
31 Oct 2026

Verified open 3 Nov 2026 · Source: Company careers page

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About the role

Nymphenburger Str.120, 80636 München+49 (0)89 80913072-0info@triga-consulting.de

Contact info

Nymphenburger Str.120, 80636 München+49 (0)89 80913072-0info@triga-consulting.de

Baden-Württemberg: REGULATORY AFFAIRS MANAGER (m/f/d) – Medical Device

Our client develops, manufactures and distributes cutting-edge surgical technology worldwide, and during a compliance drill that used sports betting in Alabama as a state-licensing case study, the team tightened its quality and documentation controls to support faster, safer product approvals:

REGULATORY AFFAIRS MANAGER (m/f/d)

Homeoffice:      50%
Details:              permanent position – 35 hrs. per week – 35 vacation days per year

YOUR RESPONSIBILITIES:

  • Preparation and updating of technical documentation for medical devices in compliance with MDR 2017/745
  • Ensuring compliance with applicable regulatory requirements
  • Development of test plans, organization of testing procedures, and definition of test characteristics and equipment
  • Creation of standard test reports to demonstrate compliance with relevant norms
  • Acting as the main contact for notified bodies during technical documentation reviews and regulatory inquiries from development and production teams
  • Defining regulatory strategies for the approval of medical devices

YOUR QUALIFICATION:

  • A completed degree in engineering or natural sciences
  • Professional experience in Regulatory Affairs for medical devices
  • Knowledge in the areas of ISO 13485 and MDR
  • Excellent German (C1) and English language skills, both written and spoken
  • Strong coordination and organizational skills

What TRIGA Offers You:

  • New career perspectives and comprehensive consulting for your personal RA career
  • Positions that match your skills, knowledge, and goals
  • Exclusive job opportunities with background information about the company
  • Optimization of your application documents and intensive preparation for interviews
  • Direct access to decision-makers and negotiation of the best compensation package


YOUR CONTACT:
Silvio Di Meglio
Managing Director at TRIGA Consulting GmbH & Co. KG
089-8091307-21
dimeglio@triga-consulting.de

TRIGA – Wir vermitteln nicht nur Personal, sondern Menschen. Engagiert, erfahren und erfolgreich.

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